The purpose of this study is to determine the maximal tolerated dose (MTD) of bortezomib and idarubicin given in combination to newly diagnosed AML patients \>60 years or relapsed AML patients. Another purpose of this study is to determine the dose limiting toxicities associated with bortezomib in combination with idarubicin in newly diagnosed AML patients \>60 years or relapsed AML patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
velcade (4 original dosing levels with 3 modified dosing levels) I.V. on days 1, 4, 8, 11, 15, 18, 22, and 25 for 4 weeks concurrent with the Idarubicin
I.V., 8, or 10 or 12 mg/m\^2 weekly (days 1, 8, 15, and 22) for 4 weeks
University of Kentucky
Lexington, Kentucky, United States
University of Rochester
Rochester, New York, United States
Maximum tolerated dose of bortezomib & idarubicin given in combination, with idarubicin given once weekly for 4 consecutive weeks & bortezomib given twice weekly over the same time.
Time frame: week 4
Dose limiting toxicities associated with bortezomib in combination with idarubicin.
Time frame: week 4
Response to the combination of Idarubicin and Bortezomib.
Time frame: Days 18 & 50
Pre- & post-treatment inhibition of NF-kB activity in the malignant & normal hematopoietic cell populations.
Time frame: 24 hours after the initial dose of Bortezomib
Induction of p53 levels in the malignant cell populations.
Time frame: 2 and 24 hours post day +1 Bortezomib
Bortezomib PK when administered to patients with acute leukemia receiving concomitant medications that could lead to drug interactions. In the case of altered pharmacokinetics, a pharmacodynamic assay to check proteasome inhibition may also be applied.
Time frame: Days 1, 4, 8, 11, 15
Idarubicin PK in order to observe any alteration in metabolism/elimination of Idarubicin & its active metabolite idarubicinol when it is combined with Bortezomib.
Time frame: Days 1, 4, 8, 11, 15
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.